Sanofi/Alnylam Say FDA Lifts Clinical Hold On Fitusiran
Zacks Investment Research | Dec 17, 2017 08:23PM ET
Sanofi (PA:SASY) (NYSE:SNY) and partner Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) announced that the FDA has lifted clinical hold placed on all ongoing studies of its hemophilia candidate fitusiran.
In September, Alnylam stopped dosing in all ongoing studies of fitusiran, a RNA interference (RNAi) therapeutic, following a death event in an open-label extension (OLE) phase II study. The patient was suffering from hemophilia A and died after developing a blood clot inside cerebral venous sinus (thrombotic event).
Alnylam and Sanofi are taking additional risk mitigation measures for fitusiran studies as there have been concerns about risks around safety in hemophilia disease. Protocol amendments and other updated clinical materials for these studies have been approved by the FDA. Dosing in fitusiran studies including OLE and phase III ATLAS studies is expected to resume around end of the year.
A look at Alnylam’s share price movement shows that the stock has massively outperformed the Zacks Investment Research
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